The lot complaint history and dhr were not reviewed, as no lot information was available for this complaint.No sample has been returned for evaluation.Therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established, as a sample has not been received.And the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known.Therefore, specific action with regards to this complaint cannot be taken.Quality assurance has reviewed this complaint.And will continue to monitor data for evidence of adverse trending and take further action as appropriate.The manufacturer internal reference number is: (b)(4).
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